BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    PMA: P060030 · Supplement: S006 · Decision Sep 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
    Trade Name
    COBAS TAQMAN HCV TEST VERSION 2.0
    PMA Number
    P060030
    Supplement Number
    S006
    Device Class
    FDA Class 2
    Product Code
    MZP
    Generic Name
    Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 1, 2010
    Date Received
    December 22, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUAL SPECIMEN PREPARATION OPTION TO THE CURRENTLY APPROVEDAUTOMATED SAMPLE PREPARATION METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND IS INDICATEDFOR:THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRONUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE HIGH PURE SYSTEM VIRAL NUCLEIC ACIDKIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS05 TAQMAN 48 ANALYZER FOR AUTOMATEDAMPLIFICATION AND DETECTION. SPECIMENS CONTAINING HCV GENOTYPES 1 THROUGH 6 HAVE BEENVALIDATED FOR QUANTITATION IN THE ASSAY.THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED INDIVIDUALS UNDERGOING ANTI-VIRAL THERAPY. THEASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE USED TO PREDICTSUSTAINED AND NON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE COBASTAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITHPEGINTERFERON ALFA-2A PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY'S PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus